Lilli Zakarija is Co-Founder and President of EdgeOne Medical Inc and has over 20 years of experience in the medical device industry. Her expertise includes development and global launch of various single-use, disposable medical devices and combination products, strategic/technical development of device platforms and IP management. Throughout her career she has held management roles in engineering and project management, and prior to founding EdgeOne Medical Lilli established and led the global engineering function supporting all device and combination product related needs for the BioScience division of Baxter Healthcare (now Baxalta a Shire company).
Lilli has a Bachelor of Science in Biomedical Engineering and a Master in Engineering Management from Northwestern University, and an Executive MBA from Kellogg School of Management. In addition, Lilli serves on the Board of Directors for Women in Bio - Chicago Chapter, Board of Advisors for Biomedical Engineering Dept at Northwestern University, is a Chicago Innovation Mentor (CIM), and is a speaker on device development and combination products.
Jim McGough is co-founder and a Board Member at EdgeOne Medical Inc. a leading global Device Development and Testing Services firm for the Pharmaceutical Industry. He is also Managing Partner of EdgeOne Venture Partners. Additionally, he is an eclectic angel investor and board member or advisor in several HealthTech and Big Data/AI ventures. Earlier in his career Jim held various Executive and Intrapreneurial leadership roles at Motorola, Audi, and Citigroup. Jim likes to be on the leading edge of technological innovation—at Audi as Head of Marketing & eBusiness he championed and led the first integration of a smart-phone via Bluetooth so that a call could seamlessly transfer from your device to your vehicle.
Jim has a Master in International Management degree in International Finance from the Thunderbird Global School of Management and has a Bachelor of Arts degree in History from the University of California at Berkeley.
Scott Ariagno is Vice President of Engineering and Development Services at EdgeOne Medical and has over 20 years in medical device and combination product design, development and manufacturing. His expertise includes development and global launch of of various single-use, disposable medical devices, infusion systems and combination products, strategic/technical development of device platforms and IP development. Throughout his career he has held management roles in engineering including heading device development and external manufacturing at Shire (now Takeda). Scott is a named inventor on over 20 patents and applications.
Scott has Bachelor of Science in Mechanical Engineering from Bradley University and a Master in Engineering Management from Northwestern University.
Jerzy Wojcik is Vice President of Quality and Regulatory Affairs Services at EdgeOne Medical Inc., and has over 25 years of industry experience in quality and regulatory affairs at Baxter Healthcare, Avery Dennison Medical (Vancive Medical), Deloitte, Abbott Laboratories and Baxter (Takeda) BioLife Plasma Services. His expertise includes identification and execution of regulatory activities across all stages of product development and lifecycle management necessary to support Class I, II and III (in both US and EU) medical device, device-biological and device-drug combination products, including wearable sensors and mobile medical applications. Jerzy also has expertise in US distribution and dispensing regulation compliance and US regulatory surveillance for drug, biologics and devices. In addition to medical product regulatory responsibilities, Jerzy also helped develop and implement quality systems and various process quality compliance initiatives.
Mr. Wojcik has a Bachelor of Science in Biology, Medical Technology and Cytotechnology from Augustana College, IL, and was an Adjunct Professor in the School of Law at Northwestern University, IL. He is a member of Regulatory Affairs Professional Society (RAPS) and volunteers with Chicago Innovation Mentors (CIM). Jerzy speaks Polish and Spanish.
Brendan Kelly is Senior Director of Quality at EdgeOne Medical and has over 20 years of engineering experience, including 15 years of direct experience in the field of medical devices. His extensive expertise includes EU MDR, FDA CFR Part 820, ISO13485, ISO14971, quality management and regulatory affairs. Throughout his career, Brendan has led numerous projects focused on enhancing enterprise quality and Quality Management Systems (QMS) both locally and on a corporate scale. His most notable leadership roles involved leading a global transition to EU MDR, multiple mergers and acquisitions, and global strategic initiatives for quality improvement and regulatory compliance. Brendan's professional qualifications include prestigious certifications from the American Society for Quality (ASQ), including Master Black Belt, Manager of Quality/Organizational Excellence, and Six Sigma Black Belt.
Brendan has a Bachelor of Engineering in Industrial Engineering and Information Systems and a Higher Diploma in Quality Assurance from the University of Galway. He also holds a Post Graduate Diploma in Project Management from the Trinity College Dublin, Ireland.